1. Field of the Invention
The invention relates to surgical instruments and methods. More particularly, the invention relates to methods and apparatus for the minimally invasive treatment of disease using an endoscope.
2. State of the Art
Minimally invasive (also known as endoscopic, laparoscopic, and arthroscopic) surgery is not a new technology. However, it is only in recent years that such surgery has become so widely accepted that it is used in many diverse procedures. Minimally invasive laparoscopic surgery typically involves the making of a small incision (5-10 mm) in the vicinity of the surgical site, the installation of a port through the incision, and the extension of a laparoscopic instrument through the port to the surgical site. Minimally invasive endoscopic surgery typically involves lubricating and inserting an endoscope through a body cavity such as the rectum or esophagus.
Gastrointestinal bleeding is a somewhat common and serious condition that can be fatal if left untreated. This problem has prompted the development of a number of endoscopic therapeutic approaches to achieve hemostasis, such as the injection of sclerosing agents, the attachment of mechanical hemostatic devices and contact electrocautery techniques. Mechanical hemostatic devices are typically in the form of clamps, clips, staples, sutures, etc. which are able to apply sufficient constrictive forces to blood vessels so as to limit or interrupt blood flow. Such devices are disclosed in U.S. Pat. No. 6,001,110. Electrocautery techniques involve the use of either monopolar or bipolar electrodes which are contacted to ulcerous tissue. A well known electrocautery device is disclosed in U.S. Pat. No. 5,336,222.
The known clip techniques and cautery techniques are only adequate for relatively small ulcers because the clips and/or cautery probes must be delivered through the working lumen of an endoscope. In particular, in addition to optical elements which carry fiber optics to illuminate the surgical site and which deliver an image from the surgical site, the endoscope typically has two or three lumena: one or two lumen (a) for aspiration and irrigation, and one (the working lumen) through which a surgical tool may be passed. The working lumen is typically very small in size (e.g., about 3 mm in diameter), and thus the size of the tools which may be used with a typical endoscope are severely limited in size. Bleeding ulcer lesions are typically 1.5 cm which is too large to be treated in one application with the known mechanicaal and electrical techniques.
Previously incorporated Ser. No. 09/730,911 discloses a medical instrument which fits over the distal end of an endoscope. As used herein, proximal end means the end closest to the practitioner and distal end means the end closest to the surgical site. The instrument includes a flexible coil having a proximal end and a distal end with a pull wire extending therethrough. An actuation device is coupled to the proximal ends of the coil and the pull wire for reciprocally moving one of the pull wire and the coil relative to the other. A pair of jaws are coupled to the distal ends of the coil and pull wire such that relative movement of the coil and pull wire causes opening and closing of the jaws. The jaws are rotatably coupled to a clevis which is adapted to be coupled to the distal end of an endoscope. At least one jaw has an xe2x80x9copenxe2x80x9d structure, with a rim but substantially no jaw cup. The jaws are U-shaped, semi-circular, or horse shoe shaped and are provided with a cautery capability by selectively coupling the coil, the pull wire, or both to a source of cauterizing energy. The clevis is attached to the distal end of an endoscope, prior to inserting the endoscope into the patient""s body, and the distal end of the endoscope is delivered to the surgical site with the aid of the optics of the endoscope and with the jaws closed by activation of the actuation device.
Many procedures require the delivery of different surgical instruments via an endoscope during the course of the procedure. Typically, the surgical instruments are delivered through one of the lumena of the endoscope. As mentioned above, however, the lumena of the endoscope are relatively small and it is often desirable to have a larger instrument at the surgical site. The previously incorporated parent application teaches how to use a relatively large instrument in conjunction with an endoscope. However, the instrument must be attached to the endoscope before the endoscope is inserted into the patient""s body.
Another issue has arisen with regard to endoscopes, particularly when an endoscope is inserted through the rectum or the esophagus, is the contamination of the endoscope and the resultant spread of disease from one patient to another. See, e.g., xe2x80x9cPatients of Brooklyn Clinic Are Sought After Outbreak of Hepatitis C,xe2x80x9d New York Times Jun. 9, 2001, http://www.nytimes.com/2001/06/09/health/09HEPA.html?searchpv=day05. Because, the optical systems in most endoscopes are relatively sophisticated and expensive, it is prohibitively expensive to dispose of an endoscope after a single use. The endoscope, including the interior of its lumena must be carefully disinfected after each use. The dimensions of the lumena make them difficult to clean thoroughly. If they are not thoroughly cleaned, the next time a surgical instrument is passed through a lumen the instrument will become contaminated.
It is therefore an object of the invention to provide methods and apparatus for the minimally invasive treatment of disease using an endoscope.
It is also an object of the invention to provide methods and apparatus for the minimally invasive treatment of disease using an endoscope and a medical instrument larger than the working lumen of the endoscope.
It is another object of the invention to provide methods and apparatus for the minimally invasive treatment of disease using an endoscope and a medical instrument which is delivered over the endoscope after the endoscope has been inserted into the patient""s body.
It is still another object of the invention to provide methods and apparatus for the minimally invasive treatment of disease using an endoscope wherein issues regarding contamination of the endoscope are minimized.
In accord with these objects which will be discussed in detail below, the present invention provides methods and apparatus for delivering a medical instrument over the exterior of an endoscope while the endoscope is installed in the patient""s body. The invention allows the elimination or covering of the working lumena in an endoscope thereby minimizing the likelihood of contamination. Furthermore, the invention also allows the use of instruments which are too large to fit through the lumena of an endoscope.
A first embodiment of an apparatus of the invention includes a sheath or collar having a radial opening, so that it can be laterally attached to the exterior of an endoscope, and a surgical tool attached to the sheath or collar. The surgical tool is controlled by a flexible coil or tube having a proximal end and a distal end with a pull wire or other actuation means extending therethrough. An actuation device is coupled to the proximal ends of the coil and the pull wire for reciprocally moving one of the pull wire and the coil relative to the other. The distal ends of the coil and pull wire are coupled to the surgical tool such that manipulation of the actuation devices results in a manipulation of the surgical tool. A method for using the first embodiment includes slipping the collar over the endoscope via the radial opening and advancing the apparatus over the endoscope to the site of the procedure.
A second embodiment of an apparatus of the invention includes a medical instrument having a plurality of straps for attaching it to the exterior of an endoscope. A method for using the second embodiment includes attaching the straps over the endoscope and advancing the apparatus over the endoscope to the site of the procedure.
A third embodiment of an apparatus of the invention includes a medical instrument attached to the end of a flexible sheath having a reclosable seam. A method for using the third embodiment includes opening the seam, slipping the sheath over the endoscope, closing the seam, and advancing the apparatus over the endoscope to the site of the procedure.
A fourth embodiment of an apparatus of the invention includes a medical instrument attached to a bifurcated cylinder having a live hinge and a locking clip. The interior of the cylinder is preferably provided with a low friction surface. A method for using the fourth embodiment includes opening the cylinder, placing the cylinder halves adjacent the endoscope, closing the cylinder around the endoscope with the locking clip, and advancing the apparatus over the endoscope to the site of the procedure.
A fifth embodiment of an apparatus of the invention includes a flexible tube having a lumen and one or more tangential sheath(s) having a radial opening. A method for using the fifth embodiment includes attaching the flexible tube to the endoscope using the one or more tangential sheath(s) either before or after the endoscope is installed in the patient, and delivering a medical instrument through the lumen of the flexible tube to the site of the procedure. At the conclusion of the procedure, the apparatus is disposed as medical waste.
A sixth embodiment of an apparatus of the invention includes a flexible tube that can be loaded onto the endoscope before or after insertion into the patient. The flexible tube has a T-shaped track and a medical instrument having a T-shaped radial extension is designed to fit inside and ride along the T-shaped track. Alternatively, the T-shaped track can be built into the exterior surface of an endoscope. A method for using the fifth embodiment includes inserting the T-shaped radial extension of the medical instrument into the track and advancing the instrument to the site of the procedure.
Additional objects and advantages of the invention will become apparent to those skilled in the art upon reference to the detailed description taken in conjunction with the provided figures.